BD (Becton, Dickinson and Company) Senior Manager, Field Assurance in Covington, Georgia
Bard has joined BD, together advancing the world of health. BD Urology & Critical Care, formerly Bard Medical, is looking to fill the position of Senior Manager, Field Assurance in Covington, GA
This position manages the Field Assurance Department from a global perspective and provides a high degree of confidence that all product complaints received on products manufactured and/or marketed by Bard Medical Division (BMD) and any of its business groups are documented and maintained in compliance to applicable Quality Systems regulations, ISO requirements, FDA regulations, and Corporate, Business Unit, and International regulations, policies and procedures. In addition, this position is responsible to ensure field actions are executed, including sending customer and regulatory agency notifications.
Establish the systems and processes for receiving and handling complaints.
Establish the systems and processes, including the assessment tools for determining and reporting eMDRs.
Establish a process by which complaints in the post market surveillance studies and clinical studies are entered in the complaint system.
Coordinates the review, investigation, and corrective actions of product complaints with manufacturing source Quality Assurance personnel to ensure consistency and attention to detail in performing and documenting complaint evaluations.
Interacts with other manufacturers to establish complaint handling, adverse event reporting, and distributor reporting responsibilities.
Establishes processes and procedures to execute field actions, globally, including customer notifications.
Ensures reporting requirements to regulatory authorities for field actions are met.
Responsible to reconcile product returned as a result of field actions and ensure product is properly disposed as required. This may require physical destruction.
Responsible and accountable for the documentation and reconciliation of all documentation related to field actions.
Coordinates with other geographies to ensure global field actions are well documented.
Interprets corporate policies and regulations as they relate to Field Assurance, and prepares and implements Business Unit procedures for conformance, when necessary.
Prepares departmental budget and operates within the budget.
Ensures the accuracy and efficiency of complaint documentation from the initial receipt of a product complaint and opening of a complaint file to the closure of the file.
Manage complaint turnaround times and corrective action follow-up.
Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department.
Serves as a contact for responding to FDA inquiries. Investigates, documents, and files adverse event reports (both domestic and international) for products marketed by BMD.
Serves as the contact for responding to MHRA inquiries. Investigates, documents, and files adverse event reports (both domestic and international) for products marketed by BMD.
Ensures that all complaints on products marketed by BMD and any of its associated business groups are received, documented, analyzed, and trended in accordance to Corporate and Business Unit policies and procedures, and applicable regulations.
Manage the Legal team, the Disposables team, the Capital Equipment team and the Laboratory Investigation team to ensure complaints are managed from intake to closure including reporting requirements, investigation and closure.
Ensures trending reports are generated and presented to upper management as required.
Coordinate worldwide exchange of complaint information.
Facilitate the communication of complaint trends to business franchise teams to ensure that compliance and business requirements are met.
Monitor user-related complaint trends. Coordinate customer in-servicing and follow-up with Sales Force and Clinical Educators.
Based on customer experience, provide input as needed into the development of sales force training materials.
Interacts with Corporate Legal in responding to litigation requests, reimbursement requests, and evaluation results requests for BMD.
When required, respond to interrogatories, collection of documents and participate in depositions.
Complaint Handling and Reporting Responsibilities
Receive complaints and follow-up to collect relevant information from the user.
Arrange for the return of complaints samples.
Direct the investigation of complaints including any bench testing.
Review existing P/DFMEAs for updates, as required.
Make clinical severity and risk assessments, classify and assign FDA defect code. Where appropriate and as necessary, discuss complaints and clinical severity with the Medical Director.
Determine whether a product complaint is a malfunction or serious injury that requires reporting to the FDA and ensure reporting within the required time frame.
Where necessary, handle FDA inquires of complaints.
Interacts with international facilities with reporting responsibilities to BMD in establishing standardization of complaint handling and MDR/vigilance compliance.
Approve all International Vigilance decision trees.
Where the complaint should be a Competent Authority Report, create the vigilance report, if required, provide any CA inquiries.
Maintain all required records for the complaints and/or eMDR Reports.
Where necessary, assign CAPA investigation.
Train customer facing staff, such as sales staff, on the complaint system and internal reporting procedure.
Lead training on GMPs/complaint handling for sales representatives.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Proficient in the use of a personal computer with intermediate level of keyboarding skills.
Strong interpersonal skills required in the areas of verbal and written communications, customer focus, service to internal customers, telephone manner, professionalism, coaching, influencing, and team building.
Strong listening and assessment skills.
Strong questioning & problem-solving skills.
Detail oriented, committed to accuracy, efficiency, and consistency.
Good proofreading skills and memory retention.
Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities.
Must be able to manage people and control stressful situations.
Must be able to maintain a calm and positive approach to negative issues and resolve day-to-day problems associated with managing the personnel and duties of the Field Assurance Department.
Must be able to maintain legible, accurate records.
Good written and verbal communication skills.
Four-year degree in science or technical field.
Minimum eight years of experience with FDA regulated industry including five years in complaint handling, MDR/adverse event reporting, and complaint investigations.
Minimum five plus years’ managerial experience.
This position works in a normal office environment. The noise level in the work environment is quiet to moderate. This position also has exposure to a laboratory environment. Must be trained in blood-borne pathogens and handling bio-hazardous materials.
Relocation Available?: yes
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
Street: 8195 Industrial Blvd.
C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.